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Botox Deaths Under Investigation in Canada

Oct 9, 2008 | Parker Waichman LLP

Five Canadians have died following Botox injections, prompting health regulators in that country to launch an investigation.  Health Canada said it is also looking into 8 reports of serious reactions following Botox treatment.  

All of the deaths occurred in people who had received Botox injections to treat medical conditions such as neck and muscle spasms.  Using Botox to treat conditions like muscle spasms requires much higher doses than what is typically used to eliminate wrinkling .

This past February, the U.S. Food & Drug Administration (FDA) launched its own investigation of botulinum toxin injections, including Botox, Botox Cosmetic, and Mylobloc. In the U.S., Botox is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).  Botox Cosmetic, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Mylobloc is approved  for the treatment of adults with cervical dystonia.

The FDA said at the time that it had received reports of adverse reactions in patients receiving the injections.  The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may have been due to overdosing.

In the U.S., the group Public Citizen has petitioned the FDA issue warnings to doctors about the hospitalizations and deaths associated with the use of botulinum toxin products. The group wants a "black box" added to product labels and an information pamphlet given to patients when the drug is injected.

The Botox reactions reported in Canada included throat swelling, respiratory arrest, difficulty swallowing and aspiration pneumonia, and infection that occurs when food or liquids are inhaled into the respiratory tract and lungs.

According to Health Canada, only one of the 13 reports it had received as of March 28 involved using Botox for wrinkles, and none was medically confirmed as "distant toxin spread."  However, "10 of the 13 cases were deemed to be serious owing to life-threatening reaction (one case), hospitalization (three cases), ongoing disability (one case) or fatal outcome (five cases)," the agency said in its most recent adverse reaction newsletter.

Two deaths  occurred in children with cerebral palsy. As is the case in the U.S., Botox has not been approved for such use in Canada. The other deaths involved three women in their 60s, all of whom had underlying medical conditions such as Parkinson's or cerebral palsy.


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